Webinar
Medical Devices

Preparing a Clinical Evaluation Report (part 1)

Preparing a good quality clinical evaluation report for submission to the notified body is vital to ensure they understand your device.

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In this Webinar:

Documenting the Device Description.
Documenting Equivalence.
Documenting Similar Devices Data.
Documenting Clinical Claims.

Speakers

Hear from the experts in this webinar

Speaker

Richard Holborow

Head of Clinical Compliance, BSI

Speaker

Adam Liddle

Head of Life Sciences- Regulatory & Policy, BSI

More webinars in the 2023 Clinical Masterclass Series

Ensure your product maintains EU market access under the new, more stringent Medical Device Regulations (MDR).

Performing a robust clinical evaluation plan is a critically important step and if not done correctly can undermine your overall clinical evaluation.

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Understand how best to document clinical investigations, including expectations around supporting documentation related to clinical investigations.

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This webinar will focus on how best to document PMCF plans and evaluation reports.

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The summary of safety and clinical performance (SSCP) is a new requirement under the MDR.

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